Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Previously presented claims are cancelled.
New claims 7-17 are pending.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7-17 are rejected under 35 U.S.C. 103 as being unpatentable over the following,
Applicant provided references of record,
Document 1: JP 2018-27078; Document 2: Goto, Proceedings of the Annual Meeting of the Japanese Society of Carbohydrate Research, 2018, vol. 37, page 138
Document 3: Goto, Abstract of the Annual Meeting of the Pharmaceutical Society of Japan, 2019, vol.139, page 139
Document 4: WO 2019/057087
Document 5: JP 2018-512374
Document 6: Zhou, International Journal of Pharmaceutics. 2015, vol. 487, no. 1-2, pp. 81-90
Document 7: JP 2018-62655
Document 8: JP 2011-515698
Document 1 teaches (Abstract)
The method for producing a compd. having a polyethylene glycol (PEG) chain
comprises using sugar hydrolase which is less expensive than
glycosyltransferase and using oxazoline deriv. (I) more stable than sugar
nucleotide as sugar donor. The method for producing the compd. into which
the PEG chain of the present invention is introduced in which a
sugar-contg. compd. is used as a sugar acceptor, a sugar deriv. having a
sugar moiety of PEG modified as a sugar donor, a sugar having a sugar
transfer activity which is characterized by transferring a PEG-modified
sugar to a sugar moiety in a sugar acceptor using a hydrolase in the
presence of I. According to the present invention, it is an unprecedented
method that can introduce a PEG chain of a predetd. structure with sugar
as a foothold at a fixed position on the protein
Document 2 teaches PEGization method of Protein Using Metastasis Activity of ENGase.
Document 3 teaches PEGization method of Protein Using Metastasis Activity of ENGase
As such Documents 1-3 teach methods for the PEGylation of proteins such as antibodies, wherein a PEG chain containing oxazoline is reacted with a peptide utilizing the transfer activity of ENGase (document 1 (claims, examples), documents 2, 3 (entire text)).
The difference is that the methods disclosed in documents 1-3 is that the PEG terminal of the PEG compound in instant claims formulae (for example see pictured structures of claim 10) is substituted with any of unsaturated rings such as an azide, tetrazine,
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whereas the PEG terminal is unmodified in the PEG compounds of documents 1-3.
Documents 4-6 is invoked to cure the deficiency of Documents 1-3:
As disclosed in documents 4-6, it is well known in regard to the PEGylation of proteins such as antibodies, that in order to provide more functional groups to such PEGylated proteins, PEG can be further modified with a conventional linker such as a group that is related to a click reaction, i.e., an unsaturated ring such as an azide, tetrazine, to link another functional structure to the linker (document 4 (claims, scheme 1-6, examples), document 5 (claims, scheme 1-5, examples), document 6 (ABSTRACT, fig.I));
and with regard to such linkers, derivative structures obtained by modifying the PEG compound with various commonly used linkers are well known, as disclosed in document 7,, and cyanobenzothiazole is a well-known linker, as disclosed in document 8 (document 7 (claims, examples), document 8 (claims, examples)). A person skilled in the art thus easily could have conceived of further providing another desired functional group to the azide sugar PEG compounds used for the PEGylation
As such all the claimed elements are known in the prior art to make modified compounds (claim 9, 10) are used to modify proteins such as antibodies (Fab region) with a functional PEG.
As such nothing unobvious is seen in the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The structural make-up of the modified immunoglobulin antibody (for example how many antibodies are in the final modification), in spite of indications with arrows, remains vague and in definite. For example, the arrows imply chemical modification of, opening of the oxazoline with OH group of the Asn containing sugar-linked to the antibody. Multiple modifications with functionalized biomolecules in addition to the pictured Asn-Fc region (see claim 14 structural formula; claim 17 pictured formula indicates further functionalization of azide with another biomolecule) are implied. It is unclear whether the modifications are needed with reactions with another biomolecule through the azide functional group (or cyclooctyne group) (for Sharpless click chemistry). Dependent claims do not solve the problem of the vagueness of the base claim. Because of the ambiguity it is unclear whether Huang, Chemoenzymatic Glycoengineering of Intact IgG Antibodies for Gain of Functions J. Am. Chem. Soc. 2012, 134, 12308−12318, Scheme 1 at page 12310, modification reads on the subject matter of the instant claims:
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Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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